Physician-Industry Relationships: Promoting Professional Integrity and Medical Progress

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1 Institute on Medicine as a Profession Physician-Industry Relationships: Promoting Professional Integrity and Medical Progress, Ph.D. Bernard Schoenberg Professor of Social Medicine Columbia College of Physicians and Surgeons President Institute on Medicine as a Profession Looking Back and Looking Ahead: 2 The So-Called Good Old Days A profession that was all male, white, uppermiddle class. Medical Professionalism: Does it have to be Revived? or Invented? Conflict of interest was certainly present: Fee-splitting, direct dispensing, fee-for-service. Resistance to organizational change: The bias against group practice; The bias against government intervention. 3 And Yet: A Distinguished Tradition of Professionalism The Hippocratic Oath Service to the underprivileged A life dedicated to serving patients 4 From Principle to Practice: Taking Professionalism Seriously The Fundamental Challenges for Professionalism in the 21st Century: What does it mean to make professionalism a force for change? 5 6

2 Attributes of Professionalism The Challenges to Professionalism Altruism and commitment to patients interests Self-regulation Maintenance of technical competence Civic Engagement Altruism and Commitment to Patients Interests above Financial Interests HMO / Hospital / Group Practice / Financial Incentives Drug and Device Company Relationships Professional Integrity and Medical Progress 7 Professional Integrity and Medical Progress 8 Conflict of Interest in the Polity and the Society Why We Say No: Core Principles Should a loan department officer dine or gift the college student loan administrator to increase referrals? Should a lobbying group dine or gift a state legislator or congressman to advance legislation? Should a brokerage house dine or gift a mutual fund administrator to attract their stock purchases? Should an apparel designer dine or gift the department store purchasing agent to seal the purchase? Should a public agency dine or gift a journalist to spin a story? Most will answer no to the above questions. Commitment to organizational integrity and client welfare. Decision-making should be free of personal bias. Gifts of any size (even small ones) are influential. Disclosure is not a sufficient cure. Professional Integrity and Medical Progress 9 Professional Integrity and Medical Progress 10 Conflict of Interest in Medicine Is there any reason why physicians and drug and device companies should be allowed to play by different rules? DIAGNOSING THE PROBLEM Professional Integrity and Medical Progress 11 Professional Integrity and Medical Progress 12

3 Marketing drugs and devices Lipitor Advertisement Companies are very aggressive in marketing their products, both to the general public and to medical professionals. Professional Integrity and Medical Progress 13 Professional Integrity and Medical Progress 14 Lipitor Advertisement Viagra Campaign with Rafael Palmeiro I Take Batting Practice (Over 500 Home Runs) I Take Infield Practice (3 Gold Gloves) I Take Viagra: Let's Just Say It Works for Me. Professional Integrity and Medical Progress 15 Professional Integrity and Medical Progress 16 Drug Companies Advertising to Consumers Device Company Marketing Expenditures Estimated 1.5 billion in trade journal ads targeting physicians Direct to Consumer Advertising increased from nearly nothing in 1996 to 50 million in 2005 Sources: Medical Marketing Blog Medical Device Product Management: Benchmarking Development, Marketing and Promotion Professional Integrity and Medical Progress 17 Professional Integrity and Medical Progress 18

4 Direct to Consumer Device Advertising Direct to Consumer Device Advertising Zimmer Gender Knee TV Ad Professional Integrity and Medical Progress 19 Professional Integrity and Medical Progress 20 Financial Relationships Between Industry and Physicians Samples Food, Gifts Speakers bureau fees Ghostwriting fees Funds for conferences and Continuing Medical Education (CME) Consulting fees Royalties Stipends and honoraria Research funding Professional Integrity and Medical Progress 21 Professional Integrity and Medical Progress 22 Headlines: The Facts Professional Integrity and Medical Progress 23 Professional Integrity and Medical Progress 24

5 Headlines: The Facts Headlines: The Implications The New York Times Professional Integrity and Medical Progress 25 Professional Integrity and Medical Progress 26 Headlines: The Implications Drug Representatives 1 rep for every 5 physicians in the U.S. Drug companies spend $12 billion/year on marketing to physicians, exclusive of drug rep salaries and journal ads Use relationship building to increase sales Dispense favorable information about their products Provide free gifts and services Are friendly, attractive, and outgoing Professional Integrity and Medical Progress 27 Professional Integrity and Medical Progress 28 Gimme an Rx Cheerleaders Pep Up Drug Sales NY Times, 11/28/05 Device Industry Response: Device Reps are not Drug Reps Known for their athleticism, postage-stamp skirts and persuasive enthusiasm, cheerleaders have many qualities the drug industry looks for in its sales force. Drug companies have found that former cheerleaders are good at persuading doctors. Field representatives, employed by device manufacturers, usually provide technical expertise and on-site support during device implantation Industry representatives are a factory-trained service department, which will go to a hospital, doctor s office, nursing home, or, in some cases, accompany a clinician to a patient s home -McCoy, F., More Than a Device: Today's Medical Technology Companies Provide Value Through Service. Cardiac Electrophysiology Review, (1): p Professional Integrity and Medical Progress 29 Professional Integrity and Medical Progress 30

6 Industry Response: A Different Kind of Rep PRESCRIPTIONS -McCoy, F., More Than a Device: Today's Medical Technology Companies Provide Value Through Service. Cardiac Electrophysiology Review, (1): p The Rise of Transparency 32 Company Disclosure Data: Spine Solutions January 30, 2008 In light of the media attention and growing awareness of conflict of interest, there is a new commitment to transparency. 33 Company Disclosure Data: Biomet July 7, Company Disclosure Data: Smith & Nephew July 7, 2008 Smith & Nephew July 7,

7 Journal of the American Medical Association January 25th, 2006 (295: ) Changing the Rules at Academic Medical Centers 37 No one wants to demonize industry. There is too much to learn to improve health care outcomes. That fact acknowledged, how can institutions insure that neither education nor research is biased by gifts and grants? How can collaborations continue without the loss of scientific integrity or the sacrifice of patient well being? Recommendations to Academic Medical Centers for Controlling Conflicts of Interest Activity Regulation Gifts, meals directly to physician from industry Eliminate Provision of free samples, other patient-use products An indirect distribution system Speakers Bureaus and Ghostwriting Eliminate Payment for physician and trainee travel Contributions to a conflict-free central facility 39 Activity Regulation Direct support for CME Contributions to a conflict-free central facility Consulting, speaking honoraria, and research contracts Transparency; Specify terms of service and be available for public inspection Formulary and other purchasing decisions Decision-makers must be conflict free 40 AMCs Leading the Way Gifts bring with them the felt need to reciprocate We re not saying you re being bribed. We re saying you re being gifted. Some of it could be raw monetary hustling. But some of it is this psychological Well, they just sent me out to Las Vegas, their drug is as good as anybody else s, why not just say thank you Recommendations to Academic Medical Centers for Controlling Conflicts of Interest NY Times, 2/12/07 41 Yale University University of Pennsylvania Stanford University University of Michigan University of Washington Kaiser Permanente UC Davis UC System University of Arizona University of Pittsburgh Boston University 42

8 Catalysts for Change Barriers to Change Leadership " Change was top down at many AMCs. Sensitivity to Media Coverage " Fear of institutional embarrassment through scandal. An Opportunity to Exercise Professional Leadership Dependency on Industry Funding. Ignorance of What Leading AMCs and Societies are Doing. Fear of Faculty Resistance Complicated Hospital/Educational Structures Professional Integrity and Medical Progress 43 Professional Integrity and Medical Progress 44 Best Practices - Gifts Best Practices - Meals Policy at University of Wisconsin, Kaiser Permanente, University of Pittsburgh, University of Michigan, Stanford University, University of California, Davis, University of Pennsylvania Physicians may not accept any gifts of any value from representatives Policy at University of Pittsburgh, University of Wisconsin, Kaiser Permanente, Stanford University, University of Michigan, University of California, Davis, University of Pennsylvania Meals provided by industry representatives may not be accepted on campus Meals provided by industry representatives off campus are discouraged Professional Integrity and Medical Progress 45 Professional Integrity and Medical Progress 46 Best Practices - Ghostwriting Looking Ahead Policy at University of Pittsburgh Personnel cannot be listed as co-authors on papers ghostwritten by Industry representatives. Personnel should always be responsible for the content of any papers or talks that they give, including the content of slides. To date, most attention has gone to drugs but that is now changing. It is devices that are increasingly the focus of media, policy, and medical center attention. Professional Integrity and Medical Progress 47 Professional Integrity and Medical Progress 48

9 Questions to Explore in Device Conflict of Interest Questions to Explore in Device Conflict of Interest What policy should govern Academic Medical Center interaction with device reps? Can formularies work as well with devices as with drugs? What are the appropriate disclosure policies? Should royalties be differentiated from consulting payments? Given Disclosure of a Significant Financial Relationship, What policies should guide Academic Medical Centers? Restrictions on teaching or research? Recusal from purchasing decisions? Restrictions on patient care? Training guidelines? Professional Integrity and Medical Progress 49 Professional Integrity and Medical Progress 50 What would the new world of medicine look like? Decisions by physicians would become more evidence-based. Expenditures on drugs and devices would decline. Increased use of generic products. A decreased reliance on inappropriate agents and procedures. A clearer and cleaner divide between marketing and education. Increased sensitivity among medical students and house staff to the values of medical professionalism and scientific integrity. Greater public respect for the profession Reduced likelihood of state and federal regulation Professional Integrity and Medical Progress 51